Skills
CAPA
Nonconformance (NC) Documentation
Quality Systems
About the Role
We’re looking for a Staff CAPA Specialist to strengthen our quality systems in a regulated environment. You’ll review and approve NC and CAPA documentation, support effective investigations, and help drive continuous improvement. This role is ideal for a collaborative problem-solver who can partner across functions and balance compliance with business needs.
Responsibilities
- Review and approve nonconformance (NC) and CAPA records for completeness, effectiveness, accuracy, timeliness, and regulatory compliance
- Approve documentation updates, CAPA extensions, and corrective action plans
- Act as the local subject matter expert (SME) and process owner for NC/CAPA procedures
- Ensure adherence to corporate and local quality requirements
- Partner with cross-functional teams to guide investigations and CAPA activities through all stages of the process
- Coach stakeholders on CAPA expectations, quality standards, and continuous improvement opportunities
Requirements
- Strong expertise in CAPA, NC processes, and quality systems in regulated settings
- Thorough understanding of documentation review, compliance expectations, and investigation lifecycle management
- Excellent attention to detail and the ability to evaluate effectiveness and root-cause quality
- Comfort working in a matrixed organization and influencing stakeholders across functions
Benefits
- Opportunity to make an impact on quality outcomes and operational improvement
- Collaborative, cross-functional environment with clear quality ownership
- Support for professional growth in regulated quality systems
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